Immunotherapy and Paraneoplastic Neurological Syndromes

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Paraneoplastic Neurological Syndromes (PNS) are rare remote effects of cancer, not directly attributed to mass lesions, metastases, infections, ischemia, coagulopathy, metabolic disruptions or tumour treatment. Currently, PNS treatment is mostly limited to tumour treatment. Because of an initial inflammatory stage early in the evolution of the PNS several immunotherapy modalities have been tried. Intravenous human immunoglobulins could be expected to provide a stabilization or even improvement of PNS, if administered early enough to prevent permanent neuronal damage.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

Inclusion criteria :

• Age ≥ 18 years

• Clinical diagnosis of PNS according to published criteria

• Positive well-characterized onconeural antibodies (Hu, Yo, CV2/CRMP5) in serum or CSF samples

• Rankin score between 2 and 4

• Less than 6 months since onset of symptoms

• Less than 3 weeks in a Rankin score between 2 and 3

• Patients who have given written informed consent

Exclusion criteria :

• Patients not be able to receive IVIg

• Patients who receive or will receive concomitant immunotherapy different from that in the protocol

• Patients with known selective deficiency of IgA

• Women of childbearing potential who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions

• Patients with psychiatric or systemic diseases that prevent the proposed treatment

• Patients who will not be able to attend the required follow-up visits

• Renal, hepatic or cardiac insufficiency, coagulopathy